Sudafed Sinus Congestion 12 Hour
- Product NDC
- 50090-4629
- 11-digit product format
- 500904629
- Labeler code
- 50090
- Product ID
- 50090-4629_51527d7c-26f4-4538-928e-f3ac2bba4f84
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Pseudoephedrine Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA075153
- Marketing category
- ANDA
- Marketing start
- 2019-06-17
- Substance
- PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 120 mg/1
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sudafed Sinus Congestion 12 Hour
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 120 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6V9V2RYJ8N |
| Rxcui | 1049154, 1049668 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-4629-0 | Sudafed Sinus Congestion 12 Hour | 10 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 10 | | 12 |
| 50090-4629-0 | Sudafed Sinus Congestion 12 Hour | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4629 | SUDAFED SINUS CONGESTION 12 HOUR (PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS] | 6 | Current NDC, Legacy NDC, 2 package rows | 20231026_0e4717a1-914b-466d-8bf0-d37ebc32fdb3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50090-4629-0 | 50090462900 | 1 BLISTER PACK in 1 CARTON (50090-4629-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2019-10-21 | 0000-00-00 | No | No | Current |